A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Simvastatin in Healthy Volunteers

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Canagliflozin (JNJ-28431754); Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01821027

28431754DIA1009 (Other Identifier)

CR015511

Details and patient eligibility

About

The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of a single dose of simvastatin.

Full description

This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), single-center, fixed-sequence study (all volunteers receive the same medication on the same days and in the same order) to determine how multiple doses of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics and pharmacodynamics of a single dose of simvastatin (a drug used to treat raised cholesterol). The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. During the open-label treatment phase, each volunteer will receive a single 40 mg dose of simvastatin on Day 1, followed by 300 mg of canagliflozin once daily on Days 2 through 6. On Day 7, volunteers will receive both simvastatin 40 mg and canagliflozin 300 mg. Each volunteer will participate in the study for approximately 32 days

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Volunteers must have a body mass index (BMI) (weight in kg/height in m2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
• Volunteers must be non-smokers

Exclusion criteria

• History of, or current active illness, considered to be clinically significant by the Investigator, or any other illness that the Investigator considers should exclude the patient from the study, or that could interfere with the interpretation of the study results

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Canagliflozin + simvastatin

Experimental group

Description:

Each volunteer will receive a single dose of simvastatin on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 2 through 6. On Day 7 volunteers will receive a single dose of simvastatin in combination with a single dose of canagliflozin.

Treatment:

Drug: Simvastatin

Drug: Canagliflozin (JNJ-28431754)